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| Stem definition | Drug id | CAS RN |
|---|---|---|
| enzymes | 5176 | 885051-90-1 |
| Molecule | Description |
|---|---|
|
Synonyms:
|
a recombinant uricase and achieves its therapeutic effect by catalyzing the oxidation of uric acid to allantoin, thereby lowering serum uric acid
|
| Dose | Unit | Route |
|---|---|---|
| 0.57 | mg | P |
None
None
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Jan. 8, 2013 | EMA | Crealta Pharmaceuticals Ireland Limited | |
| Sept. 14, 2010 | FDA | CREALTA PHARMS LLC |
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Blood uric acid increased | 90.68 | 38.35 | 17 | 347 | 7687 | 90620396 |
| Infusion related reaction | 59.39 | 38.35 | 30 | 334 | 416750 | 90211333 |
| Disseminated varicella zoster virus infection | 59.01 | 38.35 | 8 | 356 | 456 | 90627627 |
| Therapeutic response decreased | 49.26 | 38.35 | 17 | 347 | 89712 | 90538371 |
| Varicella zoster sepsis | 43.48 | 38.35 | 4 | 360 | 3 | 90628080 |
| Gout | 40.16 | 38.35 | 10 | 354 | 16849 | 90611234 |
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Blood uric acid increased | 575.79 | 42.07 | 137 | 2009 | 15410 | 42603779 |
| Infusion related reaction | 563.90 | 42.07 | 180 | 1966 | 60626 | 42558563 |
| Therapeutic response decreased | 401.94 | 42.07 | 124 | 2022 | 36888 | 42582301 |
| Blood uric acid abnormal | 186.37 | 42.07 | 28 | 2118 | 237 | 42618952 |
| Anaphylactic reaction | 129.33 | 42.07 | 56 | 2090 | 42687 | 42576502 |
| Urticaria | 91.99 | 42.07 | 53 | 2093 | 73983 | 42545206 |
| Flushing | 75.71 | 42.07 | 37 | 2109 | 36991 | 42582198 |
| Gout | 60.23 | 42.07 | 29 | 2117 | 28026 | 42591163 |
| Pruritus | 53.33 | 42.07 | 56 | 2090 | 188715 | 42430474 |
| Gouty tophus | 52.60 | 42.07 | 9 | 2137 | 182 | 42619007 |
| Chest discomfort | 49.74 | 42.07 | 34 | 2112 | 63582 | 42555607 |
| Blood uric acid decreased | 44.44 | 42.07 | 9 | 2137 | 465 | 42618724 |
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Therapeutic response decreased | 342.53 | 38.80 | 106 | 1738 | 96393 | 110491062 |
| Infusion related reaction | 326.62 | 38.80 | 147 | 1697 | 381015 | 110206440 |
| Blood uric acid increased | 300.80 | 38.80 | 70 | 1774 | 21459 | 110565996 |
| Anaphylactic reaction | 106.11 | 38.80 | 47 | 1797 | 114253 | 110473202 |
| Gout | 79.97 | 38.80 | 28 | 1816 | 36538 | 110550917 |
| Flushing | 68.97 | 38.80 | 34 | 1810 | 104702 | 110482753 |
| Chest discomfort | 52.87 | 38.80 | 34 | 1810 | 173814 | 110413641 |
| Urticaria | 48.42 | 38.80 | 41 | 1803 | 318816 | 110268639 |
| Blood uric acid decreased | 44.06 | 38.80 | 9 | 1835 | 1484 | 110585971 |
| Pruritus | 43.83 | 38.80 | 51 | 1793 | 581509 | 110005946 |
| Blood uric acid abnormal | 40.95 | 38.80 | 7 | 1837 | 439 | 110587016 |
| Disseminated varicella zoster virus infection | 39.44 | 38.80 | 8 | 1836 | 1273 | 110586182 |
None
| Source | Code | Description |
|---|---|---|
| ATC | M04AX02 | MUSCULO-SKELETAL SYSTEM ANTIGOUT PREPARATIONS ANTIGOUT PREPARATIONS Other antigout preparations |
| FDA CS | M0022307 | Urate Oxidase |
| FDA EPC | N0000175670 | Uric Acid-specific Enzyme |
| CHEBI has role | CHEBI:35845 | gout suppressant |
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Gout | indication | 90560007 | DOID:13189 |
None
None
None
None
None
None
| ID | Source |
|---|---|
| R581OT55EA | UNII |
| 4030213 | VANDF |
| C2350656 | UMLSCUI |
| CHEBI:749683 | CHEBI |
| CHEMBL1237025 | ChEMBL_ID |
| D09316 | KEGG_DRUG |
| DB09208 | DRUGBANK_ID |
| 8934 | INN_ID |
| C031545 | MESH_SUPPLEMENTAL_RECORD_UI |
| 7463 | IUPHAR_LIGAND_ID |
| 449280003 | SNOMEDCT_US |
| 765128006 | SNOMEDCT_US |
| 177180 | MMSL |
| 27504 | MMSL |
| d07688 | MMSL |
| 013513 | NDDF |
| 1011650 | RXNORM |
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Krystexxa | HUMAN PRESCRIPTION DRUG LABEL | 1 | 54396-801 | INJECTION, SOLUTION | 8 mg | INTRAVENOUS | BLA | 29 sections |
| Krystexxa | HUMAN PRESCRIPTION DRUG LABEL | 1 | 75987-058 | INJECTION, SOLUTION | 8 mg | INTRAVENOUS | BLA | 34 sections |
| Krystexxa | HUMAN PRESCRIPTION DRUG LABEL | 1 | 75987-080 | INJECTION, SOLUTION | 8 mg | INTRAVENOUS | BLA | 34 sections |